Clinical trial · Observational
Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins
Low Energy Dissection Vs. Electrocautery Qualitative Severity and Depth of Thermal Artifact in Breast Cancer Lumpectomy Shaved Surgical Margins
NCT03718442CI-TRIAL-00035428unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the qualitative severity and depth of dissection devices' associated thermal artifact in breast lumpectomy shaved margins between the use of electrocautery and low thermal energy dissection, PhotonBlade. The investigators hypothesize that the use of PhotonBlade would result in a significantly lower qualitative severity and a shorter depth of thermal artifact in breast lumpectomies shaved margins, when compared to electrocautery devices.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PhotonBlade vs Bovie for lumpectomy shaved surgical margins | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients - lumpectomy
- description
- Women who are 18 years or older, have Ductal carcinoma in situ (DCIS) or invasive breast-conserving surgery, have not had previous chest radiotherapy. 20 patients who meet above study population criteria will be enrolled in this study.Shaved margins for each lumpectomy site will be excised with either Bovie (3 sides) or PhotonBlade (3 sides) for each patient. The effect of PhotonBlade vs Bovie on pathology assessment of lumpectomy shaved surgical margins will be compared.
- interventionNames
- Device: PhotonBlade vs Bovie for lumpectomy shaved surgical margins
Primary outcomes (2)
- measure
- Severity of thermal artifact
- timeFrame
- Through study completion, an average of 6 months
- description
- The severity of the thermal artifact will be assessed by identifying the presence or absence of each the three qualitative severity zones, described previously,6 as below: * Zone I: extensive charring tissue * Zone II: fused cellular architecture * Zone III: distressed cellular architecture
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * have aged 18 years old or older. * have DCIS or Invasive breast cancer that is eligible for breast-conserving surgery. * have not had previous chest radiotherapy. * understand the study purpose, requirements, and risks. * able and willing to give informed consent. Exclusion Criteria: * None
References
Publications (6)
- BACKGROUNDACS. Breast Cancer Facts and Figures 2011-2012. (2012).
- BACKGROUNDVila J, Gandini S, Gentilini O. Overall survival according to type of surgery in young (</=40 years) early breast cancer patients: A systematic meta-analysis comparing breast-conserving surgery versus mastectomy. Breast. 2015 Jun;24(3):175-81. doi: 10.1016/j.breast.2015.02.002. Epub 2015 Feb 23. PMID 25728282
- BACKGROUNDPleijhuis RG, Graafland M, de Vries J, Bart J, de Jong JS, van Dam GM. Obtaining adequate surgical margins in breast-conserving therapy for patients with early-stage breast cancer: current modalities and future directions. Ann Surg Oncol. 2009 Oct;16(10):2717-30. doi: 10.1245/s10434-009-0609-z. Epub 2009 Jul 17. PMID 19609829
- BACKGROUNDChiappa C, Rovera F, Corben AD, Fachinetti A, De Berardinis V, Marchionini V, Rausei S, Boni L, Dionigi G, Dionigi R. Surgical margins in breast conservation. Int J Surg. 2013;11 Suppl 1:S69-72. doi: 10.1016/S1743-9191(13)60021-7. PMID 24380558
- BACKGROUNDRuidiaz ME, Cortes-Mateos MJ, Sandoval S, Martin DT, Wang-Rodriguez J, Hasteh F, Wallace A, Vose JG, Kummel AC, Blair SL. Quantitative comparison of surgical margin histology following excision with traditional electrosurgery and a low-thermal-injury dissection device. J Surg Oncol. 2011 Dec;104(7):746-54. doi: 10.1002/jso.22012. Epub 2011 Jul 8. PMID 21744349
- BACKGROUNDHaydon E. et al. Assessment of penetrating thermal tissue damage/spread associated with PhotonBlade™, Valleylab™ Pencil, Valleylab™ EDGE™ Coated Pencil, PlasmaBlade® 3.0S and PlasmaBlade® 4.0 for intraoperative tissue dissection using the fresh extirpated porcine muscle model